Methods for the detection and treatment of cardiac events

ABSTRACT

Disclosed are methods for detecting an acute myocardial infarction (i.e., a heart attack) at the earliest possible time and promptly warning the patient that he should immediately seek medical care. The present invention includes an implantable electronic system that can sense a change in the patient&#39;s electrogram that is indicative of a heart attack. If a heart attack is sensed, the device would then cause an implantable and/or externally located alarm to be actuated to warn the patient of his condition and a medical practitioner at a remote diagnostic center would receive the patient&#39;s electrogram for analysis. The patient or a caretaker would then be informed to self-inject medication through a subcutaneous, pass-through drug port that can be a separate device or integrated into the implanted device that is designed for the early detection of a heart attack. The methods of the present invention include determining if a human patient is likely to have a heart attack and, if he is, then implanting within that patient a device that can sense when a heart attack occurs and alarm the patient to take appropriate actions if a heart attack does occur.

FIELD OF USE

[0001] This invention is in the field of systems, including devicesimplanted within a human patient, for the purpose of automaticallydetecting the onset of a cardiac event and promptly providingappropriate medical care to prevent death and/or damage to the heartmuscle.

BACKGROUND OF THE INVENTION

[0002] Heart disease is the leading cause of death in the United States.A common and life-threatening complication of heart disease ismyocardial infarction resulting from a thrombus that obstructs bloodflow in one or more coronary arteries. The sooner thrombolyticmedication such as tissue plasminogen activator (tPA) or urokinase isplaced into the patient's bloodstream after the occurrence of an acutemyocardial infarction, the sooner an obstructive thrombus will bedissolved and perfusion of the myocardium will be restored. The extentof damage to the myocardium is strongly dependent on the length of timethat occurs prior to restoration of some blood flow to the heart muscle.At this time, no system exists that provides for early and automaticdetection of an acute myocardial infarction and for rapidly providingthe patient with a prescribed dose of a thrombolytic medication.

[0003] There are many patients who have implanted heart pacemakers orimplanted cardiac defibrillators (ICDs). The purpose of the pacemaker isto provide a low energy electrical stimulation pulse that causes theheart to beat at a prescribed rate. The purpose of the defibrillator isto shock the heart back into sinus rhythm after ventricular fibrillationhas been detected. However, no existing implantable pacemaker ordefibrillator is also able to detect a partial or complete blockage of acoronary artery and warn the patient that this potentially fatal eventis occurring. Furthermore, no pacemaker or ICD is presently used with anexternal communication and action system that rapidly responds to acutemyocardial infarction or reversible myocardial ischemia that is detectedby specially designed circuitry in that implanted pacemaker or ICD.

[0004] Although anti-tachycardia pacemakers and ICDs can detect heartarrhythmias and respond with electrical stimulation, none are currentlydesigned to be part of a rapid response system designed to inform thepatient as to his condition and to facilitate the injection of ananti-arrhythmic drug with a minimum time delay.

[0005] It is well known that an acute myocardial infarction can bedetected from a patient's ECG by noting an ST segment deviation (i.e.,voltage change) as compared to the voltage of the patient's TP or PQsegments. Such an ST segment deviation can be even more clearlydiscerned with electrodes implanted within the body (especially withinor in close proximity to the heart) as compared with detecting theelevated ST segment from chest and/or limb mounted electrodes.

[0006] In U.S. Pat. Nos. 6,112,116 and 6,272,379 issued to R. E.Fischell, et al, an implanted cardiosaver system is described thatincludes an automatic delivery of medication when a heart attack isdetected. These patents also teach the combination of internal andexternal alarm systems for informing the patient that a heart attack hasbeen detected. However, the long term storage of any thrombolytic oranti-thrombogenic medication within a human patient can cause adeterioration of such drugs. Except for the treatment of an acutemyocardial infarction, neither of these patents teaches how an externalsystem could be used to treat any potentially fatal or at leastworrisome cardiac event such as an arrhythmia and/or myocardial ischemiathat is caused by an elevated heart rate resulting from physical effortincluding exercise.

[0007] In U.S. Pat. No. 5,479,780 by M. Zehender, a device is describedthat has a “goal of eliminating . . . cardiac rhythm abnormality.” Inorder to accomplish this goal, Zehender requires exactly two electrodesplaced within the heart and exactly one electrode placed outside theheart. Although multiple electrodes could be used, an ideal sensor forproviding an electrogram to detect a heart attack would use a singleelectrode placed within the heart. The Zehender patent teaches thedetection of an ST segment deviation to indicate coronary ischemia andto use an implanted drug pump to release medication to treat such anischemia. However, Zehender never discusses the treatment of acutemyocardial infarction. Rather, the purpose of Zehender's invention isonly to warn of an arrhythmia caused by myocardial ischemia. Zehenderdoes not indicate that his invention could be used for the treatment ofa heart attack. Furthermore, Zehender does not consider the problem ofdrug deterioration when such a drug is stored within an implanted devicefor later release when ischemia is detected. Still further, ischemia canresult from exercise when there is progression of a stenosis in acoronary artery. Under such circumstances it would be highly undesirableto release a medication designed to treat the ischemia caused by a heartattack. Furthermore, Zehender does not describe an external system to beused in conjunction with an implanted cardiosaver device. Thus Zehenderdoes not teach the use of an external alarm means or means to have adiagnostic center always on call for immediate diagnosis of apotentially fatal heart attack or arrhythmia. Furthermore, Zehender doesnot teach an implanted drug port that can be used for rapidly providinga bolus of medication from an external source to be delivered into apatient having a heart attack by either the patient himself, a caretakerof the patient or by a paramedic from an ambulance. Although Zehenderdoes describe the use of a pacemaker or defibrillator in conjunctionwith an implanted device for detecting ischemia, he does not describeeither an external alarm system to be used with the implant, nor does hedescribe the use of an implanted drug port to be used with the pacemakeror defibrillator.

[0008] The electrical signal from the heart as measured from electrodeswithin the body is called an “electrogram”. The early detection of anacute myocardial infarction or myocardial ischemia caused by anincreased heart rate or exertion is clearly feasible by using animplantable system that notes a change in a patient's electrogram. Theimplanted device portion of such a system is defined herein as a“cardiosaver” and the entire system including the implanted cardiosaverand the external portions of the system is defined herein as the“cardiosaver system.” Furthermore, although the masculine pronouns “he”and “his” are used herein, it should be understood that the patient orthe medical practitioner who treats the patient could be a man or awoman. Still further the term; “medical practitioner” shall be usedherein to mean any person who might be involved in the medical treatmentof a patient. Such a medical practitioner would include, but is notlimited to, a medical doctor (e.g., a general practice physician, aninternist or a cardiologist), a medical technician, a paramedic, a nurseor an electrogram analyst. A “caretaker” is defined herein as a personthat can come to the aid of the patient if the cardiosaver systemindicates the occurrence of some cardiac related event such as a heartattack or ventricular fibrillation. A caretaker would include, but isnot limited to, the patient's spouse, an attendant in a nursing home, anurse or any person assigned to help take care of the patient. A“cardiac event” includes an acute myocardial infarction, ischemia causedby effort (such as exercise) and/or an elevated heart rate, bradycardia,tachycardia or an arrhythmia such as atrial fibrillation, atrialflutter, ventricular fibrillation, and premature ventricular or atrialcontractions (PVCs or PACs). The use of this invention to treat stroke,will for the purposes of this specification, also be considered to be a“cardiac event”. For the purpose of this invention, the term“electrogram” is defined to be the signal from an implanted electrodethat is placed in a position to indicate the heart's electricalactivity.

SUMMARY OF THE INVENTION

[0009] One embodiment of the present invention is an implanted medicaldevice that is an implanted cardiosaver, that can detect the occurrenceof an acute myocardial infarction (AMI), i.e., a heart attack, withinless than five minutes after it occurs and then automatically alarm thepatient that this event is occurring. The patient's warning can comefrom an alarm means implanted in the patient's body and/or from anexternally located alarm means that receives a wireless signal from thecardiosaver.

[0010] The cardiosaver system is designed to minimize damage to thepatient's heart from an acute myocardial infarction (i.e., a heartattack) by detecting the AMI at the earliest possible time and promptlywarning the patient that he should immediately seek medical care. To dothis, in addition to the implanted cardiosaver, the cardiosaver systemincludes an external alarm system located external to the patient. Theexternal alarm system provides an external alarm capable of waking thepatient if he is sleeping in addition to the internal alarm built intothe implanted cardiosaver. The external alarm system also has thecapability to transmit the cardiac event alarm and recorded electrogramdata collected by the implanted cardiosaver to a medical practitioner ata remotely located diagnostic center. It is also envisioned that theexternal alarm system could also transmit patient information such as anidentifying number, name, medical history and patient location inaddition to the electrogram. The external alarm system may be either afixed location alarm system located at the patient's normal residence ora portable alarm system that can be carried by the patient. The externalalarm system is also capable of transmitting the patient's electrogramboth prior to and in real time during the cardiac event to the medicalpractitioner.

[0011] A network operation support system at a network operation centeris another important portion of the external equipment for thecardiosaver system. The network operation support system receivescardiac event alarms from the external alarm system, identifies thepatient, finds the next available medical practitioner at thecardiosaver diagnostic center and provides a display of the patient'smedical record and electrogram data from the implanted cardiosaver forconsideration by the medical practitioner. Along with the patientmedical history, the patient medical record includes the prescriptionfor treatment of specific cardiac events, which prescription is writtenby the patient's own physician. The network operation support systemalso provides to the medical practitioner at the diagnostic center, thephone number for the emergency medical services (EMS) facility that isclosest to the patient's location and also directions to the patient'slocation. If the alarm is received from the fixed location alarm system,the emergency medical services phone number and directions are in themedical record. If the portable alarm system is used, the networkoperation support system will look up in its own internal database thephone number for the emergency medical services closest to the locationof the patient. By “closest” is meant the EMS that can arrive at thepatient's location in the shortest possible time. This shortest timedetermination could also include considerations relative to trafficconditions at the time that the emergency call is made.

[0012] The portable alarm system which will work through existing cellphone wireless networks will provide a location either by triangulationfrom the cell phone system or through a built in GPS locator capability.The network operation support system would typically be a softwarepackage run on one or more computers located in one or more networkoperation center. The diagnostic center(s) will have one or more medicalpractitioners either located at the diagnostic center or networked infrom remote sites. It is envisioned that the diagnostic center medicalpractitioner would also have the capability to communicate by phoneand/or data communication (instant messaging e-mail) to the patientand/or his personal physician to implement the most rapid treatment forthe patient.

[0013] To assure privacy of the patient's name, condition and medicalhistory, the cardiosaver system can also include a security systemcapability. This security system can include identifying the patientonly by a patient identification number that is programmed into theimplanted cardiosaver, by using computer systems whose function is tooperate the cardiosaver system while maintaining the patient's privacyusing means and by other methods that are well known in the art toprovide security for patient's names and medical records. Furthermore,it is envisioned that the patient would select a single name (typicallya first name or a nickname) that would be used by the medicalpractitioner at the diagnostic center to address the patient over atelephone line. This single name could correspond to a unique patientidentifying number. Use of current virtual private network (VPN) systemsand services can also facilitate the security of the entire cardiosaversystem by linking all the elements (external alarm system, networkoperation support system, physician's terminal for data recordmanagement and the diagnostic center) in a secure manner. The networkoperation support system database would contain patient medical recordsthat are periodically updated by the patient's physician from a secureterminal typically located at the primary office of the patient'sphysician.

[0014] The implanted cardiosaver can sense a change in the patient'selectrogram that is indicative of an acute myocardial infarction. If anacute myocardial infarction is sensed, the cardiosaver would then causean implantable and/or externally located alarm means such as an audiosound source or a subcutaneous electrical tickle to be actuated in orderto warn the patient of his condition. The patient could then promptlyseek medical care, for example, at a hospital emergency room. Havingbeen trained to recognize such an alarm, most patients would neitherfail to recognize such an indication of a cardiac event nor would theyignore such an alarm signal if it were to occur.

[0015] Since an implantable heart pacemaker or defibrillator already haswithin its structure and electronic circuitry many of the elementsrequired to function as a cardiosaver, it would be expeditious to addcardiosaver system capability to these existing devices to detect anacute myocardial infarction and provide implantable and external alarmmeans to inform the patient to take appropriate action. Specifically,most implantable pacemakers or defibrillators already have a long-livedbattery, one or more electrodes connected by a lead wire to anelectrogram amplifier within a hermetically sealed metal case andelectrogram storage capability. These same elements can be part of animplanted system that can be used to detect an acute myocardialinfarction and alarm the patient accordingly. The pacemaker ordefibrillator that includes a capability for early detection of an acutemyocardial infarction can be used to cause the external alarm system totransmit electrogram and other patient data to the diagnostic centermedical practitioner who can summon the emergency medical services topromptly get to the patient and apply pre-prescribed thrombolytic and/oranti-thrombogenic medication(s).

[0016] The implanted alarm located within the cardiosaver can be eitheran acoustic alarm, a mechanical vibration or a subcutaneous electricaltickle. Any one of these implanted signals could be appliedperiodically, for example, with a 5 second on-time every 30 secondsafter the detection of a heart attack. It is envisioned to turn theinternal alarm off after a reasonable time period that is probably lessthan 30 minutes. The external alarm would be accomplished by means of awireless (typically wireless) receiving system that causes an audioalarm to occur when a wireless signal is received from the implantedcardiosaver. The external audio alarm from the cardiosaver externalalarm system can inform the patient that heart attack has been detectedby his implanted system. It could also inform him (e.g., by apre-recorded human voice) that he should promptly take somepredetermined medication such as chewing two aspirins and/or injectingthrombolytic drugs into the implanted drug port in the cardiosaver, andthat he should wait for the arrival of emergency medical services or heshould promptly proceed to an emergency medical facility.

[0017] When the alarm signal arrives at the diagnostic center, themedical practitioner will review the electrogram data from the patient'scardiosaver. If the medical practitioner recognizes that the patient ishaving an acute myocardial infarction, the medical practitioner caninform the emergency medical services crew on an ambulance to deliver tothe patient a dosage of a thrombolytic and/or anti-thrombogenicmedication(s) to minimize damage to the patient's heart tissue. Ifischemia during exercise is recognized, the medical practitioner at thediagnostic center would ask the patient to stop exercising so that thealarm would go away. He would then inform the patient that he should seehis own physician to determine what caused the ischemia during exercise.The external alarm system could also have a patient operated initiatorthat could be used to send electrogram data both from memory storage andin real time to a medical practitioner at the diagnostic center. Thismight be done in the event of any arrhythmia including, but not limitedto premature atrial or ventricular beats, atrial fibrillation, atrialflutter or any other heart rhythm irregularities. The diagnostic centermedical practitioner could then advise the patient what action, if any,should be taken. The cardiosaver system could also be programmed to sendan alarm in the case of ventricular fibrillation so that a caretaker ofthe patient could be informed to immediately provide a defibrillationelectrical stimulus. This is procedure is practical as homedefibrillation units are now commercially available.

[0018] It is very important to note that the exact type and quantity ofmedication that the emergency medical services paramedics will deliverinto the patient at the direction of the diagnostic center medicalpractitioner will have been previously determined by the patient's ownphysician and not (typically) by the diagnostic center medicalpractitioner. This is due to the fact that the patient's own physicianis most familiar with the patient's weight, adverse reaction to somespecific medication and other factors that make the patient's physicianthe ideal person to determine in advance what treatment his patientshould receive if the patient has a heart attack or some other cardiacevent. The role of the diagnostic center medical practitioner is merelyto recognize from the electrogram that a cardiac event has occurred andto authorize the patient, the patient's caretaker or the emergencymedical services paramedics to administer the pre-prescribed drugregimen determined in advance by the patient's physician. If for somereason the patient's physician has not been given advance instructions,then the diagnostic center medical practitioner would be able toprescribe an appropriate drug regimen for that patient.

[0019] The emergency medical services crew (or the patient himself orthe patient's caretaker) can also use an external device to provide avibratory input in the region of the patient's heart after medication isinjected in order to assist in breaking up the newly formed blood clot.It is also anticipated that the implanted cardiosaver could includemeans for having a mechanical vibration impressed from inside the heartto enhance the break up of an artery blocking thrombus. The emergencymedical services paramedics could also provide a defibrillation shock ifthe patient is experiencing ventricular fibrillation.

[0020] It is believed that the cardiosaver system described herein isextremely valuable because many patients who have early symptoms of anacute myocardial infarction such as indigestion or left arm pain or evena chest discomfort very often tend to ignore these warning signs. If,for example, the patient experiences some indigestion that has anassociated elevated ST segment that is indicative of an acute myocardialinfarction, then promptly notifying the patient of this condition cansignificantly decrease the mortality and morbidity associated with acutemyocardial infarction. Furthermore, approximately 20% of all patientswho have an acute myocardial infarction have a “silent MI” with nodetectable symptoms whatsoever. This is very often the case for elderlyindividuals, particularly if they have had diabetes for many years. Theinvention described herein would be of particular value for suchpatients.

[0021] The fact that no alarm will result from symptoms that mimic anacute myocardial infarction will provide reassurance to the patientswhen such false heart attack indications occur. What is most importantis that, whenever a major heart attack occurs that compromises a largesection of the myocardium, there is generally a significant ST segmentshift that should be clearly discernible by the implanted cardiosaver.If a small area of the heart muscle is involved, it is possible that theST segment deviation will not be readily detected. However, a smallerinfarction would result in a much less serious outcome for the patient.

[0022] Another embodiment of the cardiosaver system involves theadministration (i.e., injection) of a thrombolytic, anti-platelet and/oranti-thrombogenic medication directly into the patient's bloodcirculation by means of a pass-through drug port that can be separatelyimplanted or formed into (i.e., integrated into) the implantedcardiosaver. Such a port would typically employ a septum on its outersurface whose location just under the patient's skin is easilydetectable by its shape, location and also by a tattoo mark on the skin.Such a tattoo mark would be placed on the skin directly over the centerof the port's septum. Either or both the patient or his caretaker wouldbe trained to inject an appropriate medication that has beenpre-prescribed by his physician through the patient's skin and throughthe septum located on the cardiosaver. The cardiosaver has a catheter influid communication with its drug port to deliver a bolus of theinjected medication rapidly and directly into the patient's bloodstream.One way to deliver the drug would be by means of a separate drugdelivery catheter that is in fluid communication with the cardiosaver'sdrug port. Alternatively, a drug delivery lumen in the electrical leadthat is used to sense the patient's electrogram could be used to deliverthe medication. In either case, the catheter or lead with a drugdelivery lumen (either of which is defined herein as the “medicationdelivery catheter”) would be placed so that its proximal end is joinedto the cardiosaver device and its distal end would lie in the patient'sbloodstream, typically in a vein, the superior vena cava or inside theheart itself. Such placement is well known to those medicalpractitioners who implant the electrical leads for pacemakers ofdefibrillators. A valve located at or near the distal end of themedication delivery catheter would prevent blood from entering themedication deliver catheter. This valve would automatically open whenmedication is injected by a hypodermic syringe through the septum,through the drug chamber in the cardiosaver and finally through themedication delivery catheter.

[0023] As a safety means to indicate that the distal end of the needleof the hypodermic syringe is properly situated at the bottom of the drugchamber of the drug port, a unique audio signal is emitted from thecardiosaver when the needle is properly placed. For example, if theindication of a heart attack is a 5 second sound burst every 30 seconds,then the indication of proper placement of the needle point within thedrug chamber of the drug port could be a sound that is continuous aslong as the distal end of the needle is pushing on the bottom surface ofthe drug chamber. Such a sound would assure the patient or the caretakerthat the plunger on the hypodermic syringe could be pushed forward torapidly deliver a bolus of the drug into the patient's bloodstream. Therapid delivery of a bolus of the drug would be clearly advantageous fordissolving a thrombus as compared to the comparatively slow drug releasethat could be accomplished by an implanted drug pump.

[0024] It is envisioned that the drug port would contains a liquidsolution that has the same osmolality as blood. The liquid solutionwould also contain an anti-bacterial ingredient to prevent the build upof any bacteria within the drug port or the medication deliverycatheter. The liquid solution would not typically contain anythrombolytic or anti-thrombogenic medication. A normal saline solutionthat includes any anti-bacterial substance commonly used as apreservative for liquid medications could be used for this purpose. Thisliquid solution would be replaced into the drug port after any injectionof a treatment medication has been accomplished. Furthermore, thepatient or his caretaker might usefully practice the injection of thissolution on a periodic basis, such as once a year, in order to maintaintheir competency for injecting medication on an emergency basis. It willbe of particular value for the patient or his caretaker to hear thesound that the implanted cardiosaver device produces when the needle ofthe hypodermic syringe is properly placed so that the plunger can bepushed to rapidly deliver a bolus of the drug into and through the drugport and into the patient's bloodstream. The periodic injection of theliquid solution must, of course, not cause any harm to the patient.

[0025] It is also envisioned that the drug port and cardiosavercapability could be incorporated into a pacemaker or a defibrillator.Thus, all the features described herein for a cardiosaver device, couldbe included into an implanted device that includes pacing and/ordefibrillation capabilities. Furthermore, a pacemaker or defibrillatorwith cardiosaver capabilities could be used with a separate drug portand with all the external equipment that is described herein.

[0026] It should also be understood that a cardiosaver device with adrug port would be very advantageous for medication delivery in anambulance or at a hospital or similar medical facility. Having a drugport that provides the most rapid access to the patient's bloodstreamcan save valuable time as compared to the time required to place anintravenous catheter into a patient's vein. This time saving isparticularly important for the patient and it would make the applicationof an intravenous injection much easier for the paramedics who usuallyare the first to get to such a patient. It should also be understoodthat the drug port could be used for the injection of other systemicallyadministered medications such as beta-blockers, anti-arrhythmic drugs,etc.

[0027] The type(s) of drugs that would be available for such deliverythrough a drug port are generally thrombolytic agents, anti-thrombogenicagents, anti-arrhythmic agents or a blend of more than one medication. Atypical thrombolytic agent could be tPA, urokinase, streptokinase or anysimilar agent designed to dissolve a thrombus. A typicalanti-thrombogenic medication could be ReoPro, heparin, Plavix or anysimilar medication. It is important to note that the method to decreasemorbidity and mortality from an acute myocardial infarction wouldinclude having the patient's own physician write a prescription for theexact type(s) and quantity of medication(s) that he would want thepatient to have if a heart attack or other cardiac event would occur.The type(s) and amount would depend on what is available at any time asthe best single drug or drug combination. Another consideration would beany known reaction of the patient to a particular medication. The amountof drug that is prescribed might also depend on the patient's sex andweight. For example, a 250-pound man would probably use a larger dose ordifferent type of medication as compared to a 100-pound woman. Thecardiosaver system also envisions the delivery of an anti-arrythmic drugfor specific types of arrhythmias and other potentially beneficial drugssuch as beta-blockers, nitrates, etc. that can improve the outcome forpatients who have a myocardial infarction.

[0028] It is well known that patients who have just had a heart attackbecome very fearful of a later heart attack that can be fatal or canresult in significant damage to the heart muscle. An important advantageof the cardiosaver system (including its use within a pacemaker ordefibrillator) as taught herein is that it can be used to assure thepatient that future heart attacks will be detected and treated sorapidly that his chance of surviving without significant heart damage isvery high. Therefore, a placebo effect for this device is expected todecrease the morbidity and mortality of these patients as compared topatients who do not have an implanted cardiosaver device and are notenrolled into the cardiosaver system.

[0029] Another important concept for this invention is a method fordetermining the type of patient in whom the cardiosaver should beimplanted. One such type of patient is a person who has diabetes asevidenced by a fasting blood sugar that is greater than 110 mg/dl.Therefore, the method to provide improved medical care for such apatient is to perform a blood test to determine if the fasting bloodglucose is greater than 110 mg/dl, and if it is, then determine if thepatient has at least one other predictor of an acute myocardialinfarction. These predictors would include, but are not limited to,hypercholesterolemia, high blood pressure, proteinuria exceeding 250 mgin 24 hours, a prior heart attack or ischemic stroke, age greater than65 or a family history of acute myocardial infarction. The inventivemethod that is taught herein includes the step of implanting acardiosaver device into such a patient. The method could further includethe step of making the patient part of the cardiosaver system so that hecould obtain rapid treatment for an acute myocardial infarction shouldit occur.

[0030] Another inventive method that is described herein includes afirst step of implanting a stent into the patient's coronary artery. Thenext step in this method is to implant a cardiosaver into that patientand then to have the patient perform an exercise that is comparativelystrenuous for that patient (e.g. a treadmill stress test). The next stepis to program the cardiosaver cardiac event detection thresholds usingthe electrogram data recorded by the implanted cardiosaver as abaseline. The last step in this method would to advise the patient toseek medical care if during future exercise his implanted cardiosaverindicates that he had a deviation of the ST segment of his electrogram.It should be understood that the cardiosaver could provide a differentalarm signal for ischemia caused by a heart attack as opposed toischemia caused by exertion when the patient has a narrowed coronaryartery. For example, for a heart attack, a 2-5 second on-time for anaudio alarm could be programmed to occur every 10-15 seconds but forischemia produced at the higher heart rates associated with exercise,when an ST segment deviation occurred because of a narrowed artery, thealarm could be a 1-2 second on-time every 30-60 seconds. Of course itshould be understood that a larger variety of on-times and periodsbetween alarm sounds could be used to signal for a variety of differentelectrogram signals that could be analyzed by the cardiosaver. At leasttwo of these are different alarm signals could provide a differentiationbetween ischemia during exercise as opposed to the occurrence of heartmuscle injury resulting from an acute myocardial infarction. In anycase, it is envisioned that the cardiosaver system provides thepatient's electrogram to the medical practitioner at the diagnosticcenter in the event of any pre-programmed arrhythmia such as atrialfibrillation, atrial flutter, PVCs, PACs, etc.

[0031] An important aspect of this invention is that the patient'sbaseline electrogram would be measured after the cardiosaver has beenimplanted. The baseline electrogram would be measured at rest and duringa treadmill stress test. These electrograms are made of record at leastfor review at the diagnostic center when a patient alarm occurs and alsothey could be programmed into the implanted cardiosaver device. In thisway, the medical practitioner at the diagnostic center can compare thepatient's baseline electrogram with the electrogram observed at the timewhen an alarm is indicated by the cardiosaver. By having the patient'sbaseline electrogram and his electrogram immediately before his heartattack and in real time during the heart attack, the diagnostic centermedical practitioner is able to definitely determine the nature andextent of the heart problem being experienced by the patient.

[0032] Because patient's who are predisposed to a heart attack are alsopredisposed to a stroke, it is envisioned that an inventive method fortreating stroke is accomplished by the use of the cardiosaver with adrug port as described herein. Specifically, if a patient has beentaught the symptoms of a stroke, then the patient could use thecardiosaver system to inject thrombolytic and/or anti-thrombogenicmedication through the drug port in his cardiosaver device under theadvice and guidance of the medical practitioner at the diagnosticcenter. The patient's personal physician would arrange for any sucharrangement in advance. Thus, the cardiosaver system could be used tosignificantly reduce the morbidity and mortality associated with stroke.

[0033] An important aspect of the cardiosaver system could be the use ofa “panic button” on the external alarm system. When the panic button ispressed by the patient, it sends an alarm signal to the next availablemedical practitioner at the diagnostic center who would call the patientback to help identify the problem and if necessary summon appropriateassistance. The panic button could be used by the patient for any healthevent where the patient believes help is needed. Thus the cardiosaversystem has application to many ailments other than AMI. In oneembodiment of the present invention, the external alarm system is builtinto a wireless phone (either a cell phone or a cordless phone). In thiscase, the panic button actually initiates a voice call directly to thenext available medical practitioner at the diagnostic center who wouldthen talk to the patient to help identify the problem and summon theappropriate emergency medical services paramedics if necessary. Forexample if the patient were to have a stroke, either the patient or thepatient's spouse, caretaker or partner could press the panic button,speak to a medical practitioner and be given instructions for injectingclot buster (thrombolytic) medication into the pass-through drug port ofthe cardiosaver.

[0034] Although the implanted cardiosaver could function without anexternal alarm system, the external alarm system is highly desirable.Thus, in its simplest form, the “cardiosaver system” includes theimplanted cardiosaver, a physician's programmer and an external alarmsystem. The external alarm system can provide interpretation of thenature of the alarm if the detection of different cardiac events isprogrammed into the implanted cardiosaver. The external alarm system canalso call out automatically to summon an emergency medical servicesambulance at a number programmed into the external alarm system. Thepatient can also initiate electrogram recording through manual use ofthe external alarm system if he feels something is wrong. The recordedelectrogram (from a detected cardiac event or manual patient initiation)could be read out by the physician's programmer at a later time. In thisversion, there would be no centralized monitoring service associatedwith the cardiosaver system. This version of the cardiosaver systemmight also include an implanted drug port as part of the cardiosaver.This would permit patient injection of thrombolytic agents or facilitateinjection by the emergency medical services paramedics.

[0035] A more advanced embodiment of the cardiosaver system includes animplanted cardiosaver, an external alarm system and a network operationsupport system. The implanted cardiosaver would be capable of sensing acardiac event and internally producing an alarm and store electrogramdata. The external alarm system would be capable of sounding an audioalarm near the patient and calling out to a network operation supportsystem. The network operation support system would be capable ofpresenting the patient's stored medical record along with the alarm dataincluding the electrograms stored by the implanted cardiosaver and realtime electrograms to a medical practitioner at a diagnostic center. Thediagnostic center would act as the central monitoring station forincoming cardiac event alarms.

[0036] Thus it is an object of this invention is to automatically sensethat a cardiac event has occurred by means of an implantable devicecalled a “cardiosaver” which capability can also be provided in apacemaker or defibrillator.

[0037] Another object of this invention to have a cardiosaver systemincluding an implanted cardiosaver, an external alarm system and anetwork operation support system, the implanted cardiosaver beingcapable of sensing a cardiac event and internally producing an alarm,the external alarm system being capable of sounding an audio alarm nearthe patient and calling out to a network operation support system thatincludes patient medical records, the network operation support systembeing capable of presenting the patient's stored medical record alongwith the alarm data including real time and stored electrograms to amedical practitioner at a diagnostic center.

[0038] Still another object of this invention is to use the cardiosaverto warn the patient that an acute myocardial infarction has occurred bymeans of a subcutaneous electrical tickle or an audio signal.

[0039] Still another object of this invention is to have an implantablecardiac event detection device (a cardiosaver) that sends a wirelesssignal to an external alarm system that is located in close proximity tothe patient. That external alarm system would inform the patient that hemay be undergoing an acute myocardial infarction and that an emergencymedical services ambulance has been called to bring him to a hospitaland/or that he should take certain actions such as immediately going toan emergency room and/or promptly taking or injecting certainmedications.

[0040] Still another object of this invention is to provide a means forinforming the patient that he is having an acute myocardial infarctionwhen he might otherwise ignore some particular symptom or he may nothave had any detectable symptom.

[0041] Still another object of this invention is to provide a means toprevent a patient from believing that he is having a heart attack whenin fact that is not happening.

[0042] Still another object of this invention is to provide a patientwho has either an implanted heart pacemaker or defibrillator with theadditional capability for sensing the occurrence of an acute myocardialinfarction and promptly warning the patient that an acute myocardialinfarction is occurring and further having an external alarm system thatcan result in the prompt arrival of an ambulance to treat the acutemyocardial infarction.

[0043] Still another object of this invention is to provide a means andmethod for informing patients who have no symptoms associated with anacute myocardial infarction that they are having a heart attack and theyshould immediately seek medical assistance.

[0044] Still another object of this invention is to provide a patientwith a cardiosaver system that can alarm the patient at all times forthe purpose of obtaining medical assistance for that patient and fortransmitting to a diagnostic center medical practitioner the patient'selectrogram, medical history and location and further resulting in thearrival of an emergency medical services ambulance at the patient's homeor any other location where the patient may be located, which ambulanceincludes paramedical personnel trained in the administration of drugtherapy to treat a cardiac event (heart attack or arrhythmia) or astroke.

[0045] Still another object of this invention is to provide theparamedics in an emergency medical services ambulance or the patient orthe patient's caretaker with a device to provide vibration to thepatient's heart to enhance the action of any medication delivered in theevent of an acute myocardial infarction.

[0046] Still another object of this invention is to provide a patientwith a portable external alarm system which includes an alarm means thatcan be with that patient at all times for the purpose of providingmedical assistance for that patient and for transmitting to a diagnosticcenter medical practitioner the patient's electrogram and location andfurther resulting in the arrival of an emergency medical servicesambulance at that patient's specific location.

[0047] Still another object of this invention is to have the portableexternal alarm system including a wireless phone capable of two-wayvoice communication.

[0048] Still another object of this invention is to have a panic buttonon the external alarm system of the cardiosaver system, the panic buttonallowing the patient to manually initiate an alarm to a centraldiagnostic center.

[0049] Still another object of this invention is to have the alarminitiated by the panic button be a “data alarm” similar to butdistinctly different from the alarm generated by the detection of anacute myocardial infarction.

[0050] Still another object of this invention is to have the alarminitiated by the panic button be a voice telephone call that can beanswered directly by personnel at a cardiosaver system diagnosticcenter.

[0051] Still another object of this invention is to provide a patientwho has had an acute myocardial infarction with a cardiosaver system soas to reduce the probability that he has a later heart attack because ofthe placebo effect that the use of the cardiosaver system provides.

[0052] Still another object of this invention is to teach a method forreducing morbidity and mortality associated with a patient who has anincreased probability for having a heart attack or stroke.

[0053] Still another object of this invention is to have a cardiosaver,including a cardiosaver capability within a pacemaker or defibrillator,which device includes a drug port that allows an externally located drugdelivery device (such as a hypodermic syringe) to be used to injectmedication into the patient's blood stream.

[0054] Still another object of this invention is to cause an audiosignal to be emitted by the implanted cardiosaver device when the distalend of a needle of a hypodermic syringe is positioned within the drugport so that the plunger on the hypodermic syringe can be safely pressedto deliver a bolus of medication into and through the drug port and intothe patient's bloodstream.

[0055] Still another object of this invention is to teach a method forhaving a patient determine if there is a further narrowing of a coronaryartery by causing the cardiosaver device to sense a deviation of the STsegment of his electrogram as a function of increased heart rate, forexample, during exercise.

[0056] Still another object of this invention is to have baselineelectrograms of the patient both at rest and during exercise beaccomplished; these data being made available to the reviewing medicalpractitioner at a diagnostic center and/or also stored as a baseline inthe implanted cardiosaver device.

[0057] Still another object of this invention is to have different alarmsignals when (1) an acute myocardial infarction is sensed as compared tothe alarm signal that is provided when (2) there is an ST segmentdeviation caused by ischemia during exercise (or any other cause oftachycardia) or (3) the alarm signal is a result of an arrhythmia, or(4) the alarm is manually initiated by the patient by pressing a panicbutton.

[0058] Still another object of this invention is to have different alarmsignals for different cardiac events detected by the implantedcardiosaver.

[0059] Still another object of this invention is have a fasterdetectable ST segment shift noted because the electrogram is sensed fromwithin the heart as opposed to sensing the ECG from surface electrodes.

[0060] Still another object of this invention is to teach a methodwhereby the patient or a caretaker, upon recognizing the symptoms of astroke, can use an implanted drug port to deliver medication to treatthat stoke.

[0061] Still another object of this invention is to teach a method toapply a source of ultrasonic or other vibration in the vicinity of theheart for an acute myocardial infarction or in the vicinity of the brainfor a stroke after a thrombolytic and/or anti-thrombogenic medicationhas been released into the patient.

[0062] These and other objects and advantages of this invention willbecome obvious to a person of ordinary skill in this art upon reading ofthe detailed description of this invention including the associateddrawings as presented herein.

BRIEF DESCRIPTION OF THE DRAWINGS

[0063]FIG. 1 illustrates a cardiosaver system for the detection of acardiac event and for warning the patient that a cardiac event isoccurring.

[0064]FIG. 2 illustrates a normal electrogram pattern and also shows anelevated ST segment that would be indicative of an acute myocardialinfarction.

[0065]FIG. 3 is a plan view of the cardiosaver showing the cardiosaverelectronics module and two electrical leads each having two electrodes.

[0066]FIG. 4 is a cross section of the cardiosaver electronics module atsection 4-4 of FIG. 3 showing separate sections for a battery,electronics and a header.

[0067]FIG. 5 is a cross section of the cardiosaver electronics module atsection 5-5 of FIG. 4.

[0068]FIG. 6 is a block diagram of the cardiosaver system thatillustrates the implantable and external portions of the system.

[0069]FIG. 7 illustrates a cardiosaver system that includes a devicewith cardiosaver capability plus a separate drug port.

[0070]FIG. 8 illustrates an implanted cardiosaver device with a portableexternal system and a separate pacemaker or ICD joined to thecardiosaver by a “Y” electrical connector.

[0071]FIG. 9 is a block diagram of the cardiosaver system thatillustrates the flow of data to and from a patient having a cardiacevent.

[0072]FIG. 10 is a plan view and a side view of a cardiosaver devicethat includes an integrated drug port.

[0073]FIG. 11 is a cross section of the cardiosaver device at section11-11 of FIG. 10.

[0074]FIG. 12 is a cross section of the cardiosaver device at section12-12 of FIG. 10.

[0075]FIG. 13 is a highly enlarged cross section of a cardiosaver deviceshowing details of the drug port with a fully inserted needle of ahypodermic syringe pushed against the bottom disk of a metal bellows ofthe drug port.

[0076]FIG. 14 is a top view of a distal portion of the medicationdelivery catheter.

[0077]FIG. 15 illustrates cross sections at section 15-15 of FIG. 14;the section at “A” showing the medication check valve in its closedposition and the section at “B” showing the medication check valve isshown in its open position.

[0078]FIG. 16 is a longitudinal cross section of a cardiosaver combinedelectrical lead that includes a drug delivery lumen and check valve.

DETAILED DESCRIPTION OF THE INVENTION

[0079]FIG. 1 illustrates one embodiment of the cardiosaver system 10consisting of an implanted medical device 5 which is a cardiosaver 5 andexternal equipment 7. The cardiosaver 5 consists of an electronicsmodule 11 that has two leads 12 and 15 that have multi-wire electricalconductors with surrounding insulation. The lead 12 is shown with twoelectrodes 13 and 14. The lead 15 has electrodes 16 and 17. In fact, thecardiosaver 5 could utilize as few as one lead or as many as three andeach lead could have as few as one electrode or as many as eightelectrodes. Furthermore, electrodes 8 and 9 could be placed on the outersurface of the electronics module 11 without any wires being placedexternally to the electronics module 11.

[0080] The lead 12 in FIG. 1 could advantageously be placed through thepatient's vascular system with the electrode 14 being placed into theapex of the right ventricle. The electrode 13 could be placed in theright ventricle or right atrium or the superior vena cava. It is alsoanticipated that the lead 15 could be placed into the venous circulationof the myocardium. If electrodes 16 and/or 17 are placed into a vein,such as the coronary sinus or any other vein of the myocardium, theneven a comparatively limited ischemic area of that region of themyocardium would produce a distinct electrogram indicating the earlyonset of a heart attack. The metal case of the electronics module 11could also serve as an indifferent electrode with either or bothelectrodes 13 and/or 14 being active electrodes. It is also conceivedthat the electrodes 13 and 14 could be used as bipolar electrodes. Theplacement and function of the lead 12 could be similar to that which iswell known for leads used with heart pacemakers or defibrillators(ICDs).

[0081] The lead 15 could advantageously be placed subcutaneously at anylocation where the electrodes 16 and/or 17 would provide a goodelectrogram signal indicative of the electrical activity of the heart.Again for this lead 15, the case of the electronics module 11 could bean indifferent electrode and the electrodes 16 and/or 17 could be activeelectrodes or electrodes 16 and 17 could function together as bipolarelectrodes. The cardiosaver 5 could operate with only one lead and asfew as one active electrode with the case of the electronics module 11being an indifferent electrode. The cardiosaver system described hereincan readily operate with only two electrodes.

[0082] The electronics module 11 contains a battery and electroniccircuitry that can warn the patient when an acute myocardial infarctionor an arrhythmia is occurring, can store for later readout the patient'selectrogram, and can send wireless signals 53 to and receive wirelesssignals 54 from the external equipment 7. The functioning of theelectronics module 11 will be explained in greater detail with theassistance of FIG. 6.

[0083]FIG. 1 also shows the external equipment 7 that consists of anexternal alarm system 60 and a physician's programmer 68 having anantenna 70. The physician's programmer 68 can advantageously be a laptopcomputer that is programmed with specific software to interact with theimplanted cardiosaver 5. When a laptop computer is used for this purposeit would have a receiver for receiving a wireless signal from thecardiosaver 5 and a transmitter for sending a wireless signal to thecardiosaver 5. The screen on the laptop would be used to provideguidance to the physician in communicating with the cardiosaver 5. Also,the screen would be used to display both real time and storedelectrograms that are read out from the cardiosaver 5.

[0084] In FIG. 1, the external alarm system 60 includes emergencymedical services 67 and a fixed location alarm system 160 having apatient operated initiator 55, an alarm transceiver 56, an alarm speaker57 and an antenna 161. The alarm transceiver 56 of the fixed locationalarm system 160 connects to the outside world through a telephone link65. The telephone link can be either a fixed or wireless telephoneconnection that allows the alarm transceiver 56 to call out to emergencymedical services 67. The typical fixed location alarm system 160 wouldbe built into a cordless phone with a base station/charging stand thatconnects to a standard telephone line that acts as the telephone link65. A modem 165 integrated into the alarm transceiver 56 is used to sendover the telephone link 65 the alarm detected and the electrogram datasent out from the implanted cardiosaver 5.

[0085] The purpose of the patient operated initiator 55 is to give thepatient the capability for initiating the holding in the memory of theimplanted cardiosaver a particular electrogram that the patient wishesto have shown to his doctor. A separate “panic button” 52 might be partof the patient operated initiator 55. The panic button 52 of the patientoperated initiator 55 could be pressed by the patient to cause the alarmtransceiver 56 to initiate a call to emergency medical services 67 or toa medical practitioner at a remote location in the event the patientfeels that he is undergoing a cardiac event. If such an event occurs,the patient may request advice from the medical practitioner at adiagnostic center or from his own personal physician to determine whathe should do. For example, the patient might feel a flutter in his chestfrom an atrial fibrillation and he may wish to seek advice from atrained medical practitioner as to what he should do. When the patientoperated initiator 55 is activated, a command is sent by the signal 54to the electronics module 11. When the command is received by theelectronics module 11, the patient's stored and/or real time electrogramcould be transmitted from the implanted cardiosaver 5 to the alarmtransceiver 56 and then by the alarm transceiver 56 over the telephonelink 65 to a remote medical practitioner. The remote medicalpractitioner could then analyze the electrogram data and call thepatient back to offer advice as to whether this is an emergencysituation or the situation could be routinely handled by the patient'spersonal physician at some later time.

[0086] The purpose of the physician's programmer 68 shown in FIG. 1 isto change the operating parameters of the implantable cardiosaver 5 andto read out data stored in the memory of the electronics module 11 suchas stored electrograms. This would be accomplished by sending aprogramming wireless signal 54 to the cardiosaver 5 and receivingtelemetry by the wireless signal 54 from the cardiosaver 5.

[0087] The purpose of the alarm transceiver 56 is to receive over theantenna 161 wireless signals 53 from the electronics module 11 of theimplanted cardiosaver 5 indicating the detection of a cardiac event andto warn the patient by an audio signal 58 sent to the alarm speaker 57.The audio signal 58 could be a sequence of tones and/or a speech messagethat instructs the patient as to what actions should be taken.Furthermore, the alarm transceiver 56 can, depending upon the nature ofthe signal 53, place an outgoing call over the telephone link 65 tosummon emergency medical services 67. When the detection of an acutemyocardial infarction is the cause of the alarm, the alarm transceiver56 would automatically notify the emergency medical services 67 that aheart attack has occurred and an ambulance could be sent to treat thepatient and to bring him to a hospital emergency room.

[0088] When an alarm is sent within the signal 53 that indicates that acardiac event is occurring, the modem 165 dials out and sends a messageover the telephone link 65 to the emergency medical services 67. Themessage sent over the telephone link may include the followinginformation: (1) a specific patient is having an acute myocardialinfarction or other cardiac event, (2) the patient's name, address and abrief medical history, (3) a map and/or directions to where the patientis located, (4) the patient's stored and real time electrogram, and (5)a prescription written by the patient's personal physician as to thetype and amount of drug to be administered to the patient in the eventof a heart attack. If the emergency medical services include anemergency room at a hospital, information can be transmitted that thepatient is in a car and on his way to the emergency room. In this mannerthe medical practitioners at the emergency room could be prepared forthe patient's arrival.

[0089] A portable version of the external alarm system 60 is discussedwith the aid of FIGS. 6 and 8. The functions of each portion of theexternal equipment 7 are explained in greater detail with the aid ofFIGS. 6 and 9.

[0090]FIG. 2 illustrates a typical electrogram signal from some pair ofimplanted electrodes such as the electrode 14 and the case 18 of FIG. 3.The various portions of the electrogram are shown as the Q, R, S, T andP waves. These are all shown as portions of a heavy solid line in FIG.2. The normal ST segment 3 is also shown in FIG. 2. When an acutemyocardial infarction occurs, there is typically an elevation (ordepression) of the ST segment 4 as shown by the light solid line in FIG.2. It is this deviation of the ST segment 4 (T′) as compared to theundeviated segment 3 (T) that is a clear indicator that an acutemyocardial infarction is occurring in a significant portion of thepatient's myocardium. Although an elevated ST segment 4 can be a goodindicator of an acute myocardial infarction, other indicators such as asudden change of heart rate or heart wall motion, intra-coronary bloodpressure or a sudden decrease in blood pO₂ could also be used asindependent sensing means or those signals could be used in addition tothe voltage deviation of the ST segment 4. It is important to note thatthe electrogram from implanted electrodes will provide a fasterdetection of an ST segment shift as compared to an ECG signal obtainedfrom skin surface electrodes. Thus the electrogram from implantedelectrodes as described herein is an ideal means for the earliestdetection of a heart attack.

[0091] It is anticipated that when a patient who has a stenosis in acoronary artery is performing a comparatively strenuous exercise hisheart rate increases and he can develop coronary ischemia that canresult in a deviation of the ST segment of his electrogram. This isparticularly true for patients who have undergone balloon angioplastywith or without stent implantation. Such patients will be informed bytheir own physician that, if their cardiosaver activates an alarm duringexercise, that it may be indicative of the progression of an arterialstenosis in one of the heart's arteries. Such a patient would be advisedto immediately seek medical care as the event would probably be anemergency if there were other symptoms of a heart attack, but wouldprobably be indicative of a non-emergency condition (namely theprogression of a stenosis) if there were no symptoms of a heart attack.As previously described, the implanted cardiosaver device could emit adifferent signal if there is a heart attack as compared to the signalthat would be produced if there were ischemia resulting from exercise.It is envisioned that heart rate and the rate of change of heart rateexperienced during an ST segment voltage deviation can be used toindicate which alarm should be produced by the cardiosaver.Specifically, an ST segment deviation at a near normal heart rate wouldindicate an acute myocardial infarction. An ST segment deviation whenthere is an elevated heart rate (e.g., greater than 100 bpm) wouldgenerally be indicative of a progressing stenosis in a coronary artery.In any case, if a sufficient ST segment deviation occurs that results inan alarm from the cardiosaver, the patient should promptly seek medicalcare to determine the cause of the alarm.

[0092] The method to determine if the patient has a stenosis in acoronary artery that is becoming progressively more narrowed would be asfollows:

[0093] a) implanting a stent into a patient's coronary artery;

[0094] b) implanting a cardiosaver device into that same patient;

[0095] c) advising the patient to seek medical care if the cardiosaverdevice alarms the patient during exercise.

[0096] It should be understood that, depending on a patient's medicalcondition, a vigorous exercise might be as energetic as running a longdistance or merely going up a flight of stairs. After the cardiosaver isimplanted in a patient who has undergone a stent implant, he should havea stress test to determine his level of ST segment shift that isassociated with the highest level of exercise that he can attain. Thepatient's heart rate should then be noted and the cardiosaver should beprogrammed to not alarm at slightly below that heart rate for thatobserved level of ST segment deviation. Then if at a later time thepatient experiences an increased deviation of his ST segment at thatpre-determined heart rate, then an alarm indicating ischemia can beprogrammed to occur. The occurrence of such an alarm can indicate thatthere is a progression in the narrowing of some coronary artery that mayrequire angiography to determine if angioplasty, possibly includingstent implantation, is required. If however, this same ST segmentdeviation occurs at a normal heart rate, then the alarm for an acutemyocardial infarction would be produced and an emergency situation wouldexist for the patient to obtain treatment for that condition.

[0097] The alarm signal associated with a significant ST segmentdeviation caused by an acute myocardial infarction can be quitedifferent from the alarm means associated with progressing ischemiaduring exercise. For example, during exercise the alarm signal might bean audio signal that occurs for 10 seconds every 30 seconds. A differentalarm signal, for example an audio signal lasting for 1 to 3 secondsevery 5 to 10 seconds, may be used to indicate an acute myocardialinfarction. In any case, a patient can be taught to recognize whichsignal occurs for these different circumstances so that he can takeimmediate response if an acute myocardial infarction is indicated butcan take a non-emergency response if progression of the narrowing of astenosis is indicated. It should be understood that other distinctlydifferent audio alarm patterns could be used for different arrhythmiassuch as atrial fibrillation, atrial flutter, PVC's, PAC's, etc. Acapability of the physician's programmer 68 of FIG. 1 would be to enableor disable alarms in the implanted cardiosaver for any one or more ofthese various cardiac events. Also, the intensity of the audio alarm,vibration or electrical tickle alarm could be adjusted to suit the needsof different patients.

[0098]FIG. 3 is a plan view of the implanted cardiosaver 5 showing theelectronics module 11, having a battery case 18, an electronics sectioncase 19 and a header 20. Electrical conductors placed through theplastic header 20 connect the electronics module 11 to the electricalleads 12 and 15, which have respectively electrodes 13 and 14 and 16 and17. The on-case electrodes 8 and 9 of FIG. 1 are not shown in FIG. 3. Itshould also be understood that the cardiosaver 5 can function with onlytwo electrodes, one of which could be the case 18 or 19. All thedifferent configurations for electrodes shown in FIGS. 1 and 3, such asthe electrodes 8, 9, 13, 14, 16 or 18 or the metal case 18 or 19 areshown only to indicate that there are a variety of possible electrodearrangements that can be used with the cardiosaver 5.

[0099] The metal case 19 of the electronics section of the electronicsmodule 11 is joined to the metal battery case 18 by a weld 21. On themetal case 19, a conducting disc 31 mounted onto an insulating disc 32can be used to provide a subcutaneous electrical tickle to warn thepatient that an acute myocardial infarction is occurring.

[0100]FIG. 4 is a cross section of the electronics module 11 at section4-4 of FIG. 3. Shown in FIG. 4 is the battery 22 within the metal case18 and having an end metal plate 23. The metal case 19 encloses theelectronics section 24 that has a plastic header 20 within whichelectrical connections can be made to the leads 12 and 15. Also shown inFIG. 4 is the cross section of the electrical tickle device consistingof the insulator disc 32 through which a wire 33 connects to theconducting disc 31. When an alternating voltage is applied between theconducting disc 31 and the metal case 19, the patient will experience asubcutaneous electrical tickle that can serve as a warning that somepre-programmed heart condition has been detected. The weld 21 can beused to hermetically seal the battery case 18 to the case 19 of theelectronics section 24. Also shown in FIG. 4 (and in FIG. 5) is a soundor mechanical vibration source 6 (typically in the form of apiezoelectric crystal) that can provide an audio or mechanical vibrationsignal that can be detected by the patient or, for an audio source, by aperson nearby. Such an alarm would be an indication that an acutemyocardial infarction or some other cardiac event is occurring. Thissource 6 would typically be a piezoelectric device that produces a soundthat can be readily heard. The level of intensity of either theelectrical tickle, vibration or the audio signal would be able to beprogrammed by the patient's physician to a level that is clearlyobservable but not disturbing or painful. A typical duty cycle for sucha signaling device would be an on-time of approximately 1 to 5 secondsand an off-time for a time period between approximately 10 and 60seconds. It is anticipated that the on-time and off-time could beprogrammed by the patient's physician. It is further anticipated thatthe warning signal when the patient's heart rate indicates he isperforming an exercise can be different from the signal when an acutemyocardial infarction is detected which is associated with a moremoderate heart rate. As one example of such two different signals, whenthe patient's heart rate exceeds 120 beats per minute (bpm), it isreasonable to assume that the patient is exercising. At the 120-bpmheart rate, if a deviation of the ST segment is observed, the patientmight experience an alarm on-time that occurs for a longer or shortertime and/or a longer or shorter off-time as compared to those times whenthe heart rate is below 100 bpm. Thus the patient and the diagnosticcenter medical practitioner could differentiate between a typical acutemyocardial infarction and ischemia resulting from the progression of acoronary artery stenosis. Other unique alarms could be programmed for avariety of cardiac events such as atrial or ventricular fibrillation.

[0101]FIG. 5 is a cross section of the electronics module 11 at section5-5 of FIG. 4. In FIG. 5, the case 18 and the end metal plate 23 form ahermetically sealed enclosure for the battery 22. By this constructionof having the battery case 18 formed as part of the case of theelectronics module 11, a reduced thickness for the electronics module 11can be accomplished. It is also envisioned that the battery 22 could bea separate device that is placed inside of a separate case of theelectronics module 11.

[0102]FIG. 5 also shows a battery feed-thru 25 having a terminal 26 thatis one terminal of the battery 22, the other terminal being the batterycase 18. Going through the case 19 of the electronics module 24 are twofeed-thrus 27 and 29 through which electrical connections are maderespectively to the wire 28 of the lead 12 and the wire 30 of the lead15. The feed-thrus 27 and 29 and the wires 28 and 30 are encapsulated inthe plastic of the header 20. It should be understood that, if there aremultiple electrodes in a lead, there must be more than one wire in thatlead that passes through the header 20 and electrically connects to theelectronics section 24. Furthermore, it should be understood that anylead attached to the electronics module 11 could be a detachable lead asis currently used with pacemakers and ICDs.

[0103]FIG. 6 illustrates in the form of a block diagram the entirecardiosaver system 10 consisting of the internal equipment which is theimplanted cardiosaver 5 and the external equipment 7. The left side ofFIG. 6 shows portions of the system that would be implanted in a patientwho has a comparatively high probability for having a cardiac event suchas an acute myocardial infarction or he has an implanted stent and thecardiosaver is implanted to provide an indication of the progression ofnarrowing of a coronary artery. These would be patients who have one ofthe following conditions:

[0104] 1. They have survived a first heart attack,

[0105] 2. They have survived a first stroke,

[0106] 3. They have an implanted pacemaker or defibrillator,

[0107] 4. They have atherosclerotic disease or have had bypass surgeryor have a family history of heart disease,

[0108] 5. They have had angioplasty or an implanted stent,

[0109] 6. They are elderly patients who have diabetes,

[0110] 7. They have any other condition that is associated with areasonably high probability of having a heart attack or a stroke.

[0111]FIG. 6 shows the electrodes 13 and 14 connected to an amplifier 36by the wires 34 and 35 in the lead 12 that would be typically placedinto the apex of the right ventricle. It should be understood, however,that the implanted electrodes and the lead could be outside the heart orthe electrodes could be mounted onto the case of the electronics module11 or one electrode could be the case itself. It is important to notethat the cardiosaver system 10 can operate with as few as twoelectrodes. However, the cardiosaver 5 could utilize as many as eightdifferent implanted electrodes that are situated at different locationseither inside or outside the heart. The object of having electrodes atdifferent locations would be to have a significant ST segment voltagedeviation for an infarct that might occur in a different part of theheart. For example, the greatest ST segment voltage deviation for anobstruction of the right coronary artery might occur at a differentlocation as compared with an obstruction of the left anterior descendingartery of the heart. In all cases, it is desirable to sense the maximumpossible ST segment voltage change caused by an arterial obstruction.The implanted cardiosaver 5 can be programmed by a wireless signal fromthe physician's programmer 68 to detect the maximum ST segment voltagedeviation from one of a multiplicity of electrodes and then indicate toan outside source which electrode has detected the maximum signal. Theelectrode placement could then be related by a trained medicalpractitioner to the region in the heart where the infarction hasoccurred.

[0112] Returning now to FIG. 6, the amplified electrogram signal fromthe amplifier 36 is fed into the electrogram event detector 37 and thestored electrogram circuitry 47. The electrogram event detector 36 hasthe capability to detect and differentiate between an acute myocardialinfarction, ischemia caused by exercise at an elevated heart rate, or avariety of pre-programmed arrhythmias that are enabled for detectionusing the physician's programmer 68 of the external equipment 7.Although FIG. 6 shows only one channel of an amplifier, it should beunderstood that as many as eight channels for detecting electrogramsignals could be used. The electrodes for each such channel would bepositioned inside or outside the heart to obtain an optimum electrogramsignal for determining an obstruction from some particular coronaryartery. When an ST segment voltage deviation is detected by theelectrogram event detector 37 for at least one channel of thecardiosaver, an implantable alarm means 48 causes a subcutaneouselectrical tickle, vibration or an audio warning signal to be producedthat warns the patient that an acute myocardial infarction or some otherheart problem is occurring. Of all these alarms, an audio signal wouldhave the greatest advantage because it can be heard by a caretaker aswell as by the patient.

[0113] When an ST segment deviation is detected, the stored electrogramcircuitry 47 holds a previous time period of electrogram recording in adigital, solid state memory and then proceeds to record an additionaltime period of the patient's electrogram. The previous time period couldbe as short as 10 seconds or as long as 10 minutes. The additional timeperiod could be as short as one minute or as long as 10 minutes.

[0114] One method to determine if an acute myocardial infarction hasoccurred is to determine the average voltage of the ST segment comparedto some reference voltage of the electrogram for a fixed number, N, ofheart beats. Then at some predetermined later time, T, the averagevoltage of the ST segment is measured again for this same number N ofheart beats. When a predetermined deviation of the ST segment voltage isobserved over that time period, the cardiosaver will be programmed tocause an alarm. For example, if we take N=8 and T=100 seconds, it couldbe expected that there would be a sufficient change in voltage of the STsegment to detect an acute myocardial infarction in that time period. Itshould be understood that N is ideally greater than 2 and less than 100.Furthermore, T is ideally at least 15 seconds and certainly less than300 seconds.

[0115] Another method for determining if an acute myocardial infarctionis occurring is to program the cardiosaver to observe if there is someaveraged ST segment voltage deviation that is less than that signifyinga heart attack but more than would be normally expected for that heartrate. If such an intermediary level of average ST segment voltage isobserved, the logic of the cardiosaver could then compare that averageST segment voltage with the measured value at a time −T or −2T. If thatcomparison indicated a sufficient average ST segment voltage deviationcorresponding to an acute myocardial infarction, then an alarm for anacute myocardial infarction could be made to occur. As an example, letus say that a deviation of 4 millivolts (mv) in the average value of theST segment voltage is necessary to cause an alarm but a deviationbetween successive voltage measurements of only 2 mv is sufficient forthe logic to look back in time to T=−100 seconds. Let us then say thatat time T=0 we observed a voltage deviation of 2 mv compared withvoltage at T=−100 seconds. Then at time T=+100 seconds we observed anaverage ST segment voltage deviation of 3 mv compared to the measuredvalue at T=0. The logic of the cardiosaver could be programmed to thencompare the average ST segment voltages at T=+100 seconds with the valueat T=−100 seconds which difference is 5 mv which is sufficient to causean alarm to occur. This methodology can be used to reduce the number ofacute myocardial infarction events that might go undetected.Furthermore, this methodology would allow detection of an acutemyocardial infarction to occur in a shorter period of time. This woulddecrease the time between the onset of a heart attack and the arrival ofmedical personnel to treat that heart attack or the time required to getthe prescribed medication from a storage place and inject it into thepatient by the patient himself or by a caretaker.

[0116] Returning now to other internal equipment which forms thecardiosaver 5 shown in FIG. 6, the timing circuits 49 would provide allthe timing signals required for the operation of the implanted equipment5 including a real time clock for marking the time of incidence ofdetected cardiac events, and the battery 22 would provide the electricalpower to operate all parts of the cardiosaver 5. A separate or apass-through drug port 128 that is integrated into the cardiosaver 5could be used to deliver medication directly into the patient'sbloodstream. The use of such separate or integrated drug ports isexplained in detail with the assistance of FIGS. 7 and 10-15.

[0117] The right side of FIG. 6 illustrates components of thecardiosaver system 10 that would be situated externally to the patient.There are three primary components of the external equipment 7, namely:a physician's programmer 68 with antenna 70, an external alarm system 60and a network operation support system 110. The physician's programmer68 is typically located at the office of the patient's physician. Theexternal alarm system 60 can be a fixed location alarm system 160 at alocation where a patient spends most of his time, or a portable alarmsystem 260 that the patient can carry with him. For example, the fixedlocation alarm system 160 could be placed at the patient's home or in anursing home where the patient is living and would typically operatethrough a standard telephone line. The portable alarm system 260 wouldoperate though a wireless telephone network like a cell phone. Thenetwork operation support system 110 includes at least one centrallylocated computer 130 having a patient record database 131 and diagnosticcenter terminals 132. The network operation support system 110 would belocated at one or more centrally located network operation centers thatwould have high reliability through backup power and other features of atelephone services central office. The diagnostic center terminals 132would be situated at one or more diagnostic centers where medicalpractitioners could respond to incoming cardiac event alarms.

[0118] When the electrogram event detector 37 detects any electrogramsignal for which it is programmed to alarm, the transmitter 45 is turnedon which causes a wireless signal 53 indicating the detection of acardiac event to be transmitted out of the antenna 34A, which could bethe wire 34 in the lead 12, or it could be a separate antenna. Thesignal 53 is received by the antenna 161 of the fixed location alarmsystem 160 and/or the antenna 261 of the portable alarm system 260 bothof which are external alarm systems 60 of the external equipment 7. Thefixed location alarm system 160 or the portable alarm system 260 is eachcapable of emitting an audio alarm to warn the patient that an acutemyocardial infarction (or some other heart problem) is occurring. Theaudio alarm could be a loud ringing sound, or preferably a voice wouldinform the patient that: (1) his implanted equipment indicates that hemay be having a heart attack or some other cardiac event; (2) he shouldtake some previously agreed upon medication(s) such as aspirin or evenbe injected with a thrombolytic or anti-thrombogenic agent such as tPAor heparin; (3) an emergency rescue service has been called; and (4) heshould either immediately go to a hospital emergency room or he shouldwait for an ambulance to come with paramedics who are trained to treatcardiac events such as a heart attack. Additionally, the alarm couldinclude a flashing light and/or text directions for the patient tofollow.

[0119] The fixed location and portable alarm systems 160 and 260respectively have the capability to send and receive data signals 163and 263 respectively to and from the computer 130 of the networkoperation support system 110 located at a network operation center.These data signals 163 and 263 may be produced by a modem and sent overvoice telephone connections or they may originate as data packets and betransmitted over a digital data network such as the Internet. The fixedlocation and portable alarm systems 160 and 260 respectively also havethe capability to send and receive voice telephone calls 164 and 264respectively to and from a medical practitioner telephone set 133 at adiagnostic center. This capability is used when the medical practitionersees an incoming alarm placed by the computer 130 on one of thediagnostic terminals 132 and uses the medical practitioner telephone set133 at a diagnostic center to call the patient back either on thepatient's home phone or on the built-in telephone which is part of thefixed location alarm system 160 or the portable alarm system 260.

[0120] In addition to the incoming alarm displayed on the diagnosticterminal 132, the computer 130 will also display the medical record ofthe patient from the patient record database 131.

[0121] The implanted alarm means 48 would typically be a sound,vibration or electrical tickle that had a duration of a few seconds andwould be turned on approximately every 5 to 60 seconds over a timeperiod of approximately 15 to 30 minutes. The physician's programmer 68would have the capability of adjusting the intensity of the audio alarm,the level of vibration, and/or the intensity of the subcutaneouselectrical tickle so that such an alarm is clearly discernible by thepatient. The physician using the physician's programmer 68 could traineach patient to recognize some clearly discernible signal as anindication that the patient should immediately seek medical assistance.The physician's programmer 68 would also have the capability to enableor disable the implanted alarm means 48. The physician's programmer 68might optimally be a lap top computer that includes a wireless systemfor interacting with the implanted cardiosaver 5.

[0122] Returning now to a discussion of the cardiosaver system 10, anelectrogram stored in the stored electrogram circuitry 47 as well asother device status information for the implanted cardiosaver 5 could besent via the transmitter 45 by means of a wireless signal 59 to thephysician's programmer 68. The wireless signal 59 arriving through theantenna 70 and into the physician's programmer 68 would allow aphysician to study the patient's electrogram and also receive othertelemetry data such as battery voltage of the battery 22 inside thecardiosaver 5. Additional data from the cardiosaver 5 would include (butis not limited to) the status of how each alarm generated by the alarmmeans has been programmed to respond to different cardiac events and thelength of time programmed for retaining prior electrogram data when acardiac event occurs.

[0123] The physician's programmer 68 can also receive real time (as wellas stored) electrogram data over the wireless signal 59.

[0124] The physician's programmer 68 can send a wireless signal 69 outof its antenna 70 to the receiver 44 of the command system 43. Thesecommand signals could cause various command functions 49 to take place.For example, one command function 49 would be to change the thresholdvoltage level of the ST segment deviation that indicates by means of theelectrogram event detector 37 that a heart attack has started. Anothercommand could set the number N of heartbeats that would be used in thecomputation of the average value of the ST segment voltage. Othercommand functions 49 could be used to adjust the intensity or thepattern of the audio alarm or subcutaneous tickle that warns the patientthat some heart problem is occurring. Still another set of commandfunctions would be to select which electrode(s) for electrogram voltagedetection should be enabled. Still another set of command functionscould adjust the time periods for the stored electrogram 47. Forinstance the time period for storing data prior to the detection of anacute myocardial infarction could be changed from 15 seconds to 60seconds. This type of programming is well known in the art of heartpacemakers and implantable defibrillators.

[0125] The fixed location alarm system 160 would be placed where thepatient would spend most of his time. Typically this would be at hishome, although it could also be at another site such as an assistedliving apartment or a nursing home. The distance from the cardiosaver 5to the close fixed location alarm system 160 should be less than 200meters. It is also envisioned that the patient might carry or haveplaced on his body or in his clothing a repeater (specifically therepeater 77 of FIG. 7) that could receive a comparatively short rangesignal from the implanted cardiosaver 5 and relay that wireless signalto the fixed location alarm system 160. The repeater 77 could be worn onthe patient's belt or be built into a pendant worn around the patient'sneck.

[0126] If the start of an acute myocardial infarction is indicated, thepatient could be aroused, even from sleep, by sounds emitted from thealarm speaker 57 of the fixed location alarm system of FIG. 1. Thepatient could then prepare for an emergency medical services ambulanceto come to his home to take him to an emergency care facility. It isalso conceivable that the patient's caretaker could take the patient toan emergency facility for treatment without waiting for the ambulance toarrive. If this were done, some simple means to inform the rescueservice to not send an ambulance could be accomplished by telephone orby other means within the external equipment 7. Furthermore, it isanticipated that the patient may have at his home an external heartdefibrillator system. If the patient has a heart attack that sounds thealarm from the alarm speaker 57 and the patient is unconscious becauseof ventricular fibrillation, then a caretaker might hear (or be awakenedby) the alarm and could apply voltage pulses from the defibrillator soas to save the patient's life.

[0127] Although the cardiosaver system 10 as described herein couldclearly operate as a stand-alone system, it is clearly conceivable toutilize the cardiosaver system 10 with a defibrillator or pacemaker(including a biventricular pacemaker for congestive heart failure). Asshown in FIG. 6, pacemaker circuitry 170 and/or defibrillator circuitry180 could be made part of any implanted cardiosaver device 5. Thecircuitry for the implanted portion of the cardiosaver system 10 couldalso be included within the electronics section of such a pacemaker ordefibrillator (as seen in FIG. 7). Furthermore, two separate devices(one pacemaker or one defibrillator plus one cardiosaver) could beimplanted within the same patient. Still further, the cardiosaver 5having a capability of a pacemaker 170 or a defibrillator 180 could beused with a separate or an integrated pass-through drug port.

[0128]FIG. 7 shows a pacer-cardiovertor-cardiosaver system 270consisting of an implanted pacer-cardiovertor-cardiosaver 70 andexternal associated equipment 207. A pacer-cardiovertor is definedherein as the electronic circuitry for either a pacemaker or adefibrillator or the circuitry that can both pace and/or defibrillate aheart. The implanted pacer-cardiovertor-cardiosaver 70 consists of asingle electronics module 71 that contains combined pacemaker andcardiosaver electronic circuitry, combined defibrillator and cardiosaverelectronic circuitry or all three capabilities together. The lead 72 isplaced in the patient's circulatory system; specifically, the electrode74 is typically situated in the right ventricle near the apex of theheart, and an electrode 73 can be placed in the superior vena cava or inthe right atrium or ventricle. It is further envisioned that the lead 72could have as many as eight electrodes at different locations foroptimizing the sensing of ST segment voltage deviations for obstructionsof the different coronary arteries. Each such separate or each pair ofsuch electrodes could be a separate channel for ST segment voltagedeviation measurement or for the measurement of other electrogramsignals indicating various cardiac events. The electrode 74 could be anactive electrode and a metal case of the electronics module 71 couldserve as an indifferent electrode. The lead 72 with electrodes 73 and 74could also be used for the cardiosaver portion of the electronics module71. Alternatively, a separate lead 15 having electrodes 16 and 17 couldbe used by the cardiosaver portion of the electronics module 71 inexactly the same way as has been described for the cardiosaver system 10of FIG. 1. As is the case for the lead 72, the lead 15 could have morethan two electrodes with each separate or pair of electrodes beingoptimally placed for detecting the ST segment voltage deviation from aparticular coronary artery. The fixed location system 160 including itsantenna 161, telephone link 65 and emergency medical services 67 wouldalso function as described for FIGS. 1 and 6. However, the physician'sprogrammer 75 of FIG. 7 having an antenna 76 would be used somewhatdifferently. The physician's programmer 75 differs from the physician'sprogrammer 68 of FIGS. 1 and 6 in that it would also have the capabilityfor interacting with the pacer-cardiovertor portion as well as thecardiosaver portion of the electronic circuitry within the electronicsmodule 71. Adding cardiosaver capability to existing pacemakers and/ordefibrillators would make either of those devices more valuable inprolonging the life of a human patient in whom such a combined system isimplanted. As described below with the assistance of FIGS. 10-13, asubcutaneous drug port 78 and medication delivery catheter 79 could beused with a pacer and/or defibrillator that may or may not include acardiosaver capability. Such a drug port 78 can be used for patientself-administration, caretaker, or medical practitioner injection oftherapeutic drug(s) into the patient's bloodstream. It is alsoenvisioned that the separate drug port 78 with medication deliverycatheter 79 could be implanted with the cardiosaver 5 of FIG. 1 whenthere is no associated pacemaker or defibrillator.

[0129]FIG. 7 also shows a repeater 77 that can be worn or carried by thepatient. Such a device would receive a low-level wireless signal fromthe implanted cardiosaver circuitry and it could respond in twodifferent modes. One mode would be to immediately inform the patient bya comparatively loud human voice message or other sound that an acutemyocardial infarction or other cardiac event has been detected and thathe should take some medication and/or immediately proceed to anemergency medical facility. The other mode is to act as a repeater torelay wireless signals 153 and 154 to and from respectively the fixedlocation alarm system 160. The advantage of the repeater 77 is that itcan be kept with the patient wherever he might be in or near thepatient's primary location. Also, being in very close proximity to thesource of the wireless signal from the implanted cardiosaver 70 makes iteasier to pick up the signal indicating that a cardiac event isoccurring. The repeater 77 could be placed in a pocket, worn on a belt,placed into a pendant hung around the neck or located in a specialvest-like device placed somewhere on the body of the patient.

[0130] The repeater 77 would also have a panic button 78 that wouldactivate the same actions as the panic button 52 of the fixed locationalarm system 160 described previously in the explanation of FIG. 1.

[0131]FIG. 8 illustrates a cardiosaver system 80 in which the implant 81includes a cardiosaver electronics module 11 and an implanted pacemakeror defibrillator 82. In this embodiment, the electronics module 11 has alead 83 having individual electrodes 84, 85 and 86 that also providesignals to an implanted pacemaker or defibrillator 82. The cases of theelectronics module 11 and pacemaker/defibrillator 82 may also be used asa common electrode. The sharing of the lead 83 is made possible by the“Y” adaptor 99 that connects the lead 83 to both the electronics module11 and pacemaker/defibrillator 82. It is also envisioned that either the“Y” adaptor 87 or the cardiosaver electronics module 11 might have surgeprotection circuitry to protect the cardiosaver during electricalstimulation discharges from the pacemaker/defibrillator 82. This is mostimportant when the unit 82 is a defibrillator.

[0132]FIG. 8 illustrates a cardiosaver system 80 consisting of ainternal equipment 81 and external equipment 307. The external equipment307 includes a portable alarm system 260, a base/recharger 265, aphysician's programmer 68 with antenna 70 for communicating with theinternal equipment 81, and a programmer 75 with antenna 76 forcommunicating with the implanted pacemaker/defibrillator 82. Wirelesssignals 91 and 92 to and from the pacemaker/defibrillator programmer 75from and to the implanted pacemaker/defibrillator 82 are used to programand collect data back from the pacemaker/defibrillator programmer 75 bythe patient's physician.

[0133] The cardiosaver system 80 of FIG. 8 also shows the external alarmsystem 60 being a portable alarm system 260 that the patient can takewith him when he is away from his primary location. For patient'sconfined to a fixed location like a nursing home or residence, the fixedlocation alarm system 160 of FIGS. 1, 6, and 7 may be adequate, but forpatient's who are mobile, the portable alarm system 260 would beadvantageous. A patient could certainly have both a fixed and portablealarm systems. It is envisioned that in many cases the portable alarmsystem 260 would be the only external alarm system 60 needed and abase/recharger 265 might be located by the patient's bedside for nightlyrecharging of the battery 266 of the portable alarm system 260. Itshould be understood that the cardiosaver 81 represents any of thefollowing: a cardiosaver device; a cardiosaver that includes a separatedrug port 78 as shown in FIG. 7 or a cardiosaver with an integrated drugport 128 as shown in FIGS. 10 through 13. Although the cardiosaverelectronics module 11 and pacemaker/defibrillator 82 share the lead 83,it is also conceived that they could each have separate leads.

[0134] The portable alarm system 260 can be made small enough to bereadily carried by the patient on a belt or in a pocket or purse. Theportable alarm system 260 might look very much like an existing Internetready cell phone. One button on the face of the portable alarm system260 might be labeled or have an icon identifying the button as a panicbutton 252 whose function is described with respect to the panic button52 of FIG. 1. The portable alarm system 260 would include a patientoperated initiator 255, alarm speaker 257, cardiosaver communicationantenna 261 and alarm transceiver 256 similar in function to thoseelements of the fixed location alarm system 160 of FIG. 1.

[0135] The purpose of the alarm transceiver 256 is to receive over theantenna 261 wireless signals 53 from the cardiosaver electronics module11 indicating the detection of a cardiac event and to warn the patientby an audio signal 258 sent to the alarm speaker 257. The audio signal258 could be a sequence of tones and/or a speech message that instructsthe patient as to actions to be taken. Furthermore, the alarmtransceiver 256 could then, depending upon the nature of thewireless/signal 53, place an outgoing call or send a data message usingthe cell phone circuitry 88. The call or data message would be sent overthe wireless link 95 that arrives at the network operation supportsystem 110 of FIG. 6, which is located at a central network operationcenter. The network operation support system computer 130 (shown in FIG.6) will then cause the incoming alarm message to be displayed on thediagnostic terminal 132 (shown in FIG. 6) of a medical professional. Themedical professional would then call the patient back to the cell phone88 built into the portable alarm system 260 to better ascertain thepatient's condition and to let the patient know that emergency medicalservices are on their way or to provide other medical advice. A GlobalPositioning Satellite (GPS) receiver is now being built into many cellphones.

[0136] Such a GPS receiver 87 with antenna 97 could receive positioninformation 93 from GPS satellites and this information could be passedon in data messages sent by the portable alarm system 260 to the networkoperation support system 110 of FIG. 6. Such GPS location information(or other means to determine the location of a cell phone) would allowemergency medical services to get to the patient anywhere that the cellphone circuitry 88 has sufficient signal from the cellular network tofunction. Today most digital cell phones include both paging andwireless Internet access. This capability can be utilized for the neededdata messaging for the portable alarm system 260.

[0137] It is also envisioned that instead of a GPS receiver 87, acellular network based patient locator could be used to identify thepatient's position for forwarding to the emergency medical services.

[0138] Two or more of the antennas 261, 97 and 98 may be physically thesame structure. It is envisioned that the entire circuitry of theportable alarm system 260 can be contained within the patient's cellphone. This has the added advantage to the patient of being able to usethe portable alarm system for normal telephony. The cell phone circuitry88 in FIG. 8 is that of a typical cell phone in that it can receive awireless signal 94 into its antenna 98 or transmit a wireless signal 95from its antenna 98.

[0139]FIG. 9 is a block diagram of a rapid treatment system 100 whoseobjective is to provide optimum treatment for a patient having a cardiacevent such as heart attack, arrhythmia or a stroke. The optimumtreatment involves administering to the patient a medication treatmentas pre-prescribed by the patient's own doctor in case he has such acardiac event. The administration of the medication should beaccomplished as quickly as possible with the optimum treatment delaybeing less than 15 minutes and with an extremely high probability ofproviding the medication within 30 minutes. Furthermore, the optimumtreatment can involve the intravenous injection of either or both athrombolytic agent or an anti-thrombogenic medication and theapplication of mechanical vibration in the vicinity of the heart orbrain to enhance the breaking up of an artery blocking blood clot. Inthe case of the detection of an arrhythmia, the medication that is to bedelivered would be an anti-arrhythmia medication.

[0140]FIG. 9 shows a rapid treatment system 100 for an implantedcardiosaver 5 with portable alarm system 260. The rapid treatment system100 would operate as follows:

[0141] 1. When a cardiac event is detected by the cardiosaver 5, thecardiosaver sends an alarm detected message over the wireless signal 53to the alarm transceiver 256 of the portable alarm system 260. Thewireless signal 53 includes an input alarm signal into the alarmtransceiver 256 as well as stored and real time electrogram data fromthe implanted cardiosaver 5.

[0142] 2. The alarm transceiver sends an alarm message 111 to thenetwork operation support system 110 located in the network operationcenter 102. The alarm message 111 includes an output alarm signal fromthe alarm transceiver 256 as well as stored and real time electrogramdata from the implanted cardiosaver 5.

[0143] 3. The network operation support system 110 in the networkoperation center 102 then identifies the next available medicalpractitioner at the diagnostic center 103 and transmits data 113 d thatis displayed on the screen of the medical practitioner at the diagnosticcenter 103. The data 113 d includes the information received from thealarm transceiver 256 (e.g. alarm type and electrogram data), the phonenumber(s) of emergency medical services nearest to the patient'slocation as well as the relevant patient medical records and prescribedtreatments stored in the database of the network operation supportsystem 110 as described with the assistance of FIG. 6. Directions to thepatient's location could be included as well as baseline electrogramdata from earlier recordings taken at the office of the patient'spersonal physician.

[0144] 4. The medical practitioner at the diagnostic center 103 can thencall the patient back with a voice call 118 to ascertain the patient'sstatus and to give instructions and assurances that his alarm has beenreceived. This concept for closing the loop with the patient isanalogous to the use of burglar alarm systems in a home that aretriggered by the opening of a door when the alarm system is enabled. Inthat case, there is also an alarm message by telephone sent to somemonitoring center and a return telephone call from the center to aperson in the house.

[0145] 5. The medical practitioner at the diagnostic center 103 couldthen call the emergency medical services 67 nearest the location of thepatient to order an ambulance and, if so prescribed, the medications forthe paramedics to administer upon arrival at the patient's location.

[0146] 6. The medical practitioner at the diagnostic center 103 couldthen have a voice message 114 v and/or 115 v to the patient's physician105 to inform that physician of his patient's status. If the patient'sphysician 105 is available either at his office 104 or by other meanshaving remote data receiving capability, the electrogram data can alsobe sent by data message 114 d or 115 d for the physician's review.

[0147] 7. If the patient is near his primary location, the physician 105or an on-call doctor for the practice would be informed of the hospital149 to which the ambulance of the emergency medical services 67 will betaking the patient. The physician 105 can then meet his patient at thehospital 149 if he elects to do so.

[0148] The transmission of these data can be originated eitherautomatically in the event that a cardiac event occurs (e.g., a heartattack) for which the system is programmed to be activated in case ofsuch an event, or the patient can be provided with a panic button 252 tomake a direct phone call 109 into the diagnostic center 103. The phonecall 109 would be routed through the network operation center 102 sothat as the routed call 113 v is received by a medical practitioner, theappropriate patient record over data line 113 d is automaticallydisplayed on the screen of the medical practitioner at the diagnosticcenter 103.

[0149] Such call routing and simultaneous data display is well known inthe field of automatic call distribution systems provided by PBX orCentrex manufacturers and designed to work with Automatic NumberIdentification (ANI) sent through the public telephone network.

[0150] The patient would also be able to use the panic button line 109to obtain a consultation from the medical practitioner at the diagnosticcenter 103 if he senses that there is something wrong with his heart andno alarm has been triggered. For example, if the patient is experiencingPVC's or PAC's, which are both fairly common and benign afflictions, hecould trigger the panic button 252 for a review of his electrogram by atrained medical practitioner at the diagnostic center 103. The medicalpractitioner would then communicate with the patient over the line 118as to what the analysis of his situation reveals. This capability couldalso be used if the patient experiences a stroke or other health relatedevent where it is necessary to summon the emergency medical services 67.

[0151] When summoned, the diagnostic center 103 would provide to theemergency medical services 67 a sub-set of the data that the medicalpractitioner at the diagnostic center 103 has received. These data wouldinclude any or all of the following: (1) the patient's name; (2) thepatient's location; (3) directions to the patient's location; (4) ananalysis of the patient's condition; and (5) directions and theauthority for administering medication(s) to the patient. If the panicbutton 252 is activated, the medical practitioner at the diagnosticcenter 103 would also call by the voice line 114 v to the office of thepatient's physician 104. If the patient's physician was not available athis office, the diagnostic center 103 could use the voice message 115 vto directly call the patient's physician 105. In the event of anemergency medical condition of the patient, it is expected that theemergency medical services 67 would have its ambulance bring the patientto the hospital 149. The patient's physician 105 would also be informedso that he could assume the care of his patient at the hospital 149. Itis also conceived that the patient would inform the diagnostic center103 that he or his caretaker is taking him directly to the hospital andthat emergency medical services are not necessary.

[0152] Although most of the voice and data communication described forthe rapid treatment system 100 would be by ground telephone or fiberoptic lines or by use of the ground-based cellular network(s), the useof orbiting communication satellites is clearly possible. If a personwas traveling to a country where there was no cellular network, he coulduse a cell phone that utilizes satellite communication to enter therapid treatment system 100 in order to gain advice about a cardiacevent. For example, an American traveling through Africa could use acell phone designed for satellite communication to enter the system 100.He could also carry appropriate drugs with him for self-treatment ortreatment by a caretaker should a heart attack occur.

[0153] One other feature of the present invention shown in FIG. 9 is amechanical vibrator 300 that can be applied to the patient's chest overhis heart after heart attack medication has been injected into thepatient's bloodstream. The application of ultrasonic or other types ofvibration can provide a more rapid breakup of a blood clot in a coronaryartery, thus providing more rapid perfusion of the patient's myocardium.It is also envisioned that such a vibrator 300 could be applied to thepatient's head if medication is delivered to treat a stroke.

[0154]FIG. 10 shows a top view and a plan view of a cardiosaver device120 that includes an integrated pass-through drug port 128 that iscapable of rapidly delivering a medication into the patient'sbloodstream. It should be understood that the intravascular drugdelivering cardiosaver 120 could include the capability of a pacemakerand/or a defibrillator. The cardiosaver 120 has a case 121, a septum 122and an exit port 123 connected to an exit tube 124. An endovascular orsubcutaneous lead 125 would be connected to the cardiosaver 120 in amanner as is well known in the art of pacemakers. The lead 125 couldhave as few as one or as many as eight electrodes that feed into theelectronics module 127 (of FIG. 11). The lead can also include a drugpassageway for delivering medication into the patient's bloodstream. Thedrug passageway could include a check valve near its distal end toprevent the inflow of blood into that drug delivery passageway. The case121 could also act as an indifferent electrode for the cardiosaver 120.

[0155]FIG. 11 is a cross section of the cardiosaver 120 at section 11-11of FIG. 10. FIG. 11 shows a drug chamber 130, a battery 126 and anelectronics module 127 all contained within the cardiosaver 120. FIG. 12is a cross section of cardiosaver 120 at section 12-12 of FIG. 10. Shownin both FIGS. 11 and 12 is the septum 122 that is the outermost part ofthe drug port 128 that is shown in greater detail in FIG. 13. Also shownin FIGS. 11 and 12 is a

[0156]FIG. 13 shows a highly enlarged cross section of the drug port 128of the cardiosaver 120 that has a case 121 to which an electricalinsulating disc 136 is attached. Both FIGS. 12 and 13 show the crosssection of the electrical lead 125 and the electrical insulating disk136 that separates the conducting surface 137 from the metal case 121 ofthe cardiosaver 120. In FIG. 12, the contact points 134 attached to thebottom plate 133 of the bellows 132 do not make contact with the topsurface of the conducting surface 137. As seen in FIG. 13, when thepoint of a non-coring needle 140 attached to a hypodermic syringe (notshown) is pushed downward against the bottom plate 133 of the metalbellows 132, at least one of the contact points 134 will close anelectrical circuit that will cause a unique audio signal to be generatedby the circuitry within the electronics module 127 of the cardiosaver120. This signal will inform the patient, caretaker, paramedic ormedical professional who has placed the needle through the patient'sskin that he can now push down on the plunger of the hypodermic syringeto deliver medication through the medication delivery catheter 152directly into the patient's bloodstream. When the medication isdelivered in this manner through the opening 141 in the needle 140, thetype and quantity of drug(s) as prescribed by the patient's physicianwill be rapidly injected into the patient's bloodstream. The medicationwill flow from opening 141 through the drug chamber 130, out the exittube 124, through the exit port 123 and finally out of the medicationdelivery catheter 152 having a check valve 153 located near its distalend. The unique audio signal indicating that the needle 140 is in itsproper place in the drug chamber 138 can be a continuous sound or arapid succession of audio pulses or any other audio signal that isdistinctly different from the alarm audio signals that are related tothe detection of a cardiac event.

[0157] An important advantage in the use of the cardiosaver 120 is thatthe patient or the patient's caretaker can keep on hand the amount andtype of medication(s) that the patient's doctor has prescribed for thatpatient. For example, an amount of tPA, urokinase, ReoPro or any othermedication or blend of medications that would be used for rapidtreatment in the event of an alarm signifying a heart attack (or astroke) could be kept where the patient and/or his caretaker couldreadily get it. The medication may be stored in a refrigerator, possiblyalready within a hypodermic syringe. The medication could also be keptin the form of a powder and mixed with a solvent at the time when it wasrequired for injection. A travel pack that includes the prescribedmedication and a means for its delivery through the drug port 128 of thecardiosaver 120 could also be provided for when the patient is away fromhis home. The patient or his caretaker could also have a source ofmechanical vibration to apply to the patient's chest over his heart toenhance the action of the delivered medication in breaking up a bloodclot that is blocking a coronary artery. The patient or his caretakercould also have on hand an external defibrillator to treat the patientif defibrillation is needed.

[0158] Although the needle 140 in FIG. 13 is shown being placed awayfrom the center of the septum 122, a patient or his caretaker would tryto place the needle through a tattoo mark 143 that is placed over thecenter of the septum after the cardiosaver 120 is implanted. The shapeof the tattoo mark on the patient's skin could be a dot, a small circle,a crosshairs or any other shape that clearly marks the location of thecenter of the septum 122. The color of the tattoo should be differentfrom normal marks found on the patient's skin. The location of theseptum 122 could also be discerned by feeling it directly under thepatient's skin.

[0159]FIGS. 14 and 15 show details of a distal portion of the medicationdelivery catheter 150 through which medication is to be delivered intothe patient's bloodstream. The medication delivery catheter 150 isessentially a cylindrical tube 152 that is closed at its distal end andhas a check valve 155 located just proximal from its distal end. When nomedication is being delivered through the medication delivery catheter150, the check valve 155 has a closed slit 154A as shown in FIGS. 14 and15A. When a bolus of medication is being delivered by means of a drugdelivery device (such as a hypodermic syringe) through the cardiosaver120, (or through a separate drug port or a drug port used with apacemaker or defibrillator) the elastomer sheath 153 will open to allowthe medication to flow through the open slit 154B and into the patient'sbloodstream. By this means and method, a patient having an acutemyocardial infarction can be rapidly treated to prevent damage to hisheart muscle. Also, anti-arrhythmic medication could be delivered inthis manner if the cardiac event detected by the cardiosaver 120 is apotentially dangerous arrhythmia.

[0160] The medication delivery catheter 150 would optimally be anon-kinking type of plastic tube that is well known in the art ofimplanted catheters. The elastomer sheath 153 might advantageously beformed from silicone rubber that could be shrink fit over the closedslit 154A. After the cardiosaver 150 is implanted like a pacemakerbeneath the patient's skin, the drug port can be accessed at regularintervals (e.g., once a year) by the patient, his caretaker or hisphysician to push through an anti-bacterial, sterile solution to verifythat the access port is still viable. This procedure would also serve asa training exercise for the patient or his caretaker by causing theneedle-in-place audio signal to be created so that that function of thecardiosaver 120 can be verified.

[0161]FIG. 16 shows the longitudinal cross section of a catheter-lead350 that is a combined electrical lead and medication delivery catheter.It is clearly envisioned to be able to combine the lead 125 of FIG. 13with the medication delivery catheter 150 of FIGS. 14 and 15. FIG. 16shows a hollow tube 351 that encloses a drug lumen 352 that terminatesin a slit 353 covered by an elastomer sheath 354. The operation of thismedication delivery catheter portion of the catheter-lead 350 would bethe same as described for the medication delivery catheter 150 of FIGS.14 and 15. The solid elastomer end section 355 of the catheter-lead 350would prevent the drug from passing through the entire length of thecatheter-lead 350. Also shown in FIG. 16 is a helical coil wire 356 thathas an electrical connecting section 357 at that place along thecatheter-lead 350 where the slit 353 is located. It should be understoodthat, although side slits are shown in FIGS. 14-16, the check valvecould also be located at the distal end of either the medicationdelivery catheter 150 or the combined catheter-lead 350.

[0162] It is envisioned that the cardiosaver systems described hereinwould be of particular value to diabetic patients who are well known tohave an acute myocardial infarction without any discernible symptoms. Amethod for helping such patients would be as follows:

[0163] (a) test the patient to determine if his fasting blood sugarexceeds 110 mg/dl, thereby indicating that he is a diabetic;

[0164] (b) determine if the patient is a likely candidate for an acutemyocardial infarction because he has had either one, several or all ofthe following coronary problems: hypercholesterolemia, high bloodpressure, a prior stroke, a prior heart attack; proteinuria with a levelexceeding 250 mg in a 24 hour period, atherosclerotic disease within hiscoronary arteries, bypass surgery or a family history of heart attacks,a homocysteine level greater than 9 mcmol/L, a c-reactive protein levelgreater than 1.1 mg/dl, an age over 65 years; and

[0165] (c) implant a cardiosaver within the patient, the cardiosaverhaving the capability for determining that an acute myocardialinfarction is occurring and warning the patient that he should seekemergency medical assistance.

[0166] Such a method when used for diabetic patients could significantlyreduce morbidity and mortality associated with acute myocardialinfarction. The method including just items (b) and (c) above would alsobe valuable for preventing death from a heart attack.

[0167] Although throughout this specification all patients have beenreferred to in the masculine gender, it is of course understood thatpatients could be male or female. Furthermore, although the onlyelectrogram indication for an acute myocardial infarction that isdiscussed herein is a deviation of the ST segment, it should beunderstood that other changes in the electrogram (depending on where inthe heart the occlusion has occurred and where the electrodes areplaced) could also be used to determine that an acute myocardialinfarction is occurring. Furthermore, sensors such as heart motionsensors, or devices to measure pressure, pO₂ or any other indication ofan acute myocardial infarction could be used independently or inconjunction with a ST segment deviation detector to sense a cardiacevent.

[0168] It is expected that patient's undergoing one or more symptoms ofa stroke could use the cardiosaver system to have an anti-thrombogenicmedication and/or a thrombolytic medication injected through animplanted drug port to reduce damage to the brain. Upon the occurrenceof such symptom(s), the patient could contact a medical practitioner atthe diagnostic center to verify if he (the patient) should have such apre-prescribed medication injected. Such a system could use a screeningprocedure by which patients who are prone to a hemorrhagic stroke wouldnot be allowed to utilize this system. Screening out potential patientswho might have a hemorrhagic stroke includes determining if suchpatients have an aneurysm in a coronary artery or an arterio-venousmalformation in the cerebral circulation. Patients who have had episodesof atrial fibrillation, transient ischemic attacks (TIAs), a prior heartattack or ischemic stroke could use the method described herein forheart attack patients that utilize a drug port and external networkoperation support system to gain medical assistance for theadministration of a drug to decrease the morbidity and mortalityassociated with ischemic stroke.

[0169] Various other modifications, adaptations, and alternative designsare of course possible in light of the above teachings. Therefore, itshould be understood at this time that, within the scope of the appendedclaims, the invention can be practiced otherwise than as specificallydescribed herein. Furthermore, for the purposes of these claims, theword “including” shall have the same meaning as “comprising” and theword “designed” or “for” shall have the same meaning as “adapted”.

What is claimed is:
 1. A method to decrease the extent of damage to theheart muscle and lower the fatality rate for a human patient who has aheart attack, the method including the following steps: (a) determiningif the human patient has a condition that is a risk factor for a heartattack, the condition being selected from the group that includes atleast one of the following: a prior heart attack, a prior stroke, afamily history of heart disease, a family history of stroke, coronaryatherosclerosis, proteinuria greater than 250 ng in a 24 hour period,diabetes with a fasting blood glucose level greater than 110 mg/dl, aprior coronary bypass surgery operation, hypercholesterolemia, ahomosysteine level greater than 9 mcmol/L, a c-reactive protein levelthat is greater than 1.1 mg/dl; and (b) implanting into the humanpatient a cardiosaver device that is designed to cause an alarm to occurthat can be sensed by the human patient if a sensor plus electroniccircuitry of the cardiosaver device indicates the occurrence of a heartattack.
 2. The method of claim 1 further including the additional stepof injecting medication through an implanted pass-through drug port thatis part of the cardiosaver device, the medication being injected throughthe drug port when the cardiosaver device indicates that a heart attackhas occurred, the medication being selected from the group that includesat least one of the following: a thrombolytic medication or ananti-thrombogenic medication.
 3. The method of claim 2 wherein thethrombolytic medication is selected from the group that includes tPA,urokinase or streptokinase.
 4. The method of claim 2 wherein theanti-thrombogenic medication is selected from the group that includes atleast one of the following: RePro, heparin or Plavix
 5. The method ofclaim 2 further including the additional step of having a personinjecting medication into the pass-through drug port, the person beingselected from the group that includes one of the following: the humanpatient, the caretaker of the human patient, a medical practitioner or aparamedic from an ambulance.
 6. A method to inform certain humanpatients that a heart attack is occurring, the method comprising thefollowing steps: (c) testing the human patient to determine if thatsubject has a fasting blood glucose that is greater than 110 mg/dl; (d)determining if the human patient has a condition selected from the groupthat includes at least one of the following conditions: a prior heartattack, a prior stroke, a family history of heart disease, a familyhistory of stroke, coronary atherosclerosis, proteinuria greater than250 ng in a 24 hour period, a homosysteine level greater than 9 mcmol/L,a c-reactive protein level greater than 1.1 mg/dl, age over 65 years, aprevious coronary bypass surgery operation, or hypercholesterolemia; (e)if the fasting blood sugar is greater than 110 mg/dl, and at least oneof the conditions listed in (b) above exists, then implanting within thehuman patient a cardiosaver device that is adapted to detect theoccurrence of heart attack using an implanted sensor and electronicsmodule which together are designed to trigger an alarm that informs thehuman patient that a heart attack is occurring.